Approved r-DNA Drugs Need No Separate Export NOC for Brand Name Change: CDSCO
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has clarified that a separate export no-objection certificate (NOC) is not necessary for recombinant DNA (r-DNA) drugs already covered by valid Indian marketing authorisation when exported under a different brand name, as long as all other approved product particulars remain unchanged.
The clarification was issued through a notice dated October 12, 2026, bearing reference number r-DNA-15011(12)/119/2026-eoffice (E-office No. 41325). Issued under the Directorate General of Health Services, Government of India, the notice addresses the requirement for an Export NOC for already approved r-DNA products.
According to CDSCO, various stakeholders had raised queries about whether a separate Export NOC was necessary to export r-DNA drug products that had already received its approval.
The regulator clarified that a firm holding a valid marketing authorisation in Form CT-23 for a particular r-DNA drug product, and seeking product permission in Form 28-D for export of the same product, would not require a separate Export NOC from CDSCO, subject to three conditions:
The product must be the same as the product already authorised under the valid marketing authorisation.
There must be no change in the approved composition, specifications, strength, dosage form, presentation, packaging configuration, manufacturing site, manufacturing process or other critical product particulars.
The only difference must be the brand name proposed exclusively for export purposes.
Explaining the basis for the clarification, CDSCO said the product had already been evaluated and granted marketing authorisation. Where there is no substantive change in the product or its approved quality attributes, using a different brand name exclusively for export does not, by itself, necessitate a separate Export NOC.
Eligible applicants may therefore directly apply for product permission in Form 28-D for export purposes through the ONDLS portal to the concerned State Licensing Authority (SLA), without obtaining a separate Export NOC from CDSCO.
The concerned authority will subsequently process the application and forward it to the Central Licensing Approving Authority (CLAA) for consideration and approval, in accordance with the applicable statutory and regulatory requirements.
The notice expressly limits this clarification to cases where the identity and approved quality attributes of the product remain unchanged and the proposed export-specific brand name is the sole difference from the already authorised product.
For all other r-DNA products or cases falling outside these conditions, firms must continue to obtain a Quantity-Specific Export NOC from CDSCO under the existing regulatory procedure.
The notice addressed to all State and Union Territory Drugs Controllers and all stakeholders. Stakeholders have been advised to take note of the clarification and comply accordingly.
To view the official notice, click the link below:
